NexGen® Legacy® 5996-15-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024001466), received between Jun 9, 2023 and Oct 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

35 other recalls cover devices cleared under the same FDA submission (K173057, K960279, P060037); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO PAIN AND MALPOSITION OF THE DEVICE. THE PATIENT REQUIRED A RIGHT KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, SHE EXPERIENCED PAIN IN HER RIGHT KNEE AND BOOKED AN APPOINTMENT WHEREUPON SHE UNDERWENT FURTHER TESTS. SHE WAS INFORMED THAT THE KNEE HAD ROTATED AND THAT IT NEEDED TO BE REVISED. THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23426941 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO ALLERGY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17098356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K960279, P060037. One submission often covers many models, so check the product and lot details in each record.

• Z-1039-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
• Z-1038-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0324-2020 · Oct 10, 2019 · Terminated
  LPS-MOB ART SURF IMPL D 9MM
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1035-2018 · Nov 29, 2017 · Terminated
  LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL
• Z-1043-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPT
• Z-1036-2018 · Nov 29, 2017 · Terminated
  LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L
• Z-1037-2018 · Nov 29, 2017 · Terminated
  LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device
• Z-1038-2018 · Nov 29, 2017 · Terminated
  LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
• Z-1034-2018 · Nov 29, 2017 · Terminated
  LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
• Z-1044-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FL
• Z-1045-2018 · Nov 29, 2017 · Terminated
  NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
• Z-1040-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
• Z-0663-2018 · Jul 24, 2017 · Terminated
  NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

…and 20 more.